Senior Specialist Quality Assurance- Biochemistry

Senior Specialist Quality Assurance - BiochemistryAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with a high employer contribution.Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.The Opportunity This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine, Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.The Senior Specialist Quality Assurance - Biochemistry leads quality assurance initiatives by ensuring regulatory compliance, managing risk, driving quality system effectiveness, supporting product lifecycle quality activities, and providing technical leadership across cross-functional teams.What You'll Work OnMaintain and enhance Quality System effectiveness, ensuring compliance with site, divisional, corporate, and regulatory requirements.Lead and manage quality-focused projects, defining objectives, milestones, timelines, and delivering successful outcomes.Provide innovative and compliant solutions to complex quality and operational challenges while aligning with organizational goals.Ensure Quality System compliance by identifying, addressing, and escalating nonconformance issues as appropriate.Conduct risk assessments and develop risk management documentation to identify, evaluate, mitigate, and control product and process risks.Investigate and resolve complex product testing issues, ensuring thorough analysis, documentation, and effective corrective actions.Support Design Control and Change Management processes, including change justification, impact assessments, and identification of critical parameters.Serve as a Quality Engineering leader, driving quality initiatives from product development through launch while collaborating with cross-functional teams and suppliers.Act as a Subject Matter Expert (SME) for validation activities, providing technical guidance and ensuring validation compliance.Mentor and train quality professionals and technicians, influencing project direction, supporting decision-making, and promoting quality excellence across the organization.Required QualificationsBachelors degree in Life Science, Engineering, or closely related discipline. Or an equivalent combination of education and work experience.Minimum 5 years in quality or related field experience; Less experience may be appropriate with advanced degree.Preferred QualificationsMasters degree is preferred.Supervisory experience is a plus.Solid understanding of diagnostic product manufacturing and testing, including diagnostic methods and applications.Proven expertise in troubleshooting, product and process improvement, QC release testing, change control, compliance, and audit readiness (internal and external).Demonstrated ability to lead cross-functional projects, test method optimization, and test method reliability improvementsDemonstrated knowledge and testing experience of bioanalytical methods (mass spectrometry, UV-Vis and infrared spectroscopy, ddPCR, HPLC, SDS-PAGE, Capillary Electrophoresis, western/dot blot).Familiarity with performance metrics and their application in driving continuous improvement.The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted. Abbott